TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
FDA 510(k) clearance K010920 · decided 2001-06-22
Clearance details
- K-number
- K010920
- Device name
- TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
- Applicant
- Medical Cables, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-27
- Decision date
- 2001-06-22
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- HEL
- Device class
- 2
- Regulation number
- 884.2660
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Costa Mesa, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| US SENSOR #CG-930P; TOCO SENSOR CG-940P (K003876) | Card Guard Scientific Survival , Ltd. | 2001-07-09 |
| COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER (K982651) | Corometrics Medical Systems, Inc. | 1998-12-11 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006 (K971240) | Alexander Mfg. Co. | 1997-06-06 |
| SONICAID MODEL TEAM FECG IUP (K930714) | Oxford Instruments, Plc. | 1995-08-24 |
| SONICAID MODEL P110 FETAL HEAR DETECTOR (K933816) | Oxford Instruments, Plc. | 1994-12-22 |
| MINIVISOR (K780035) | Metrix Teknika, Inc. | 1978-03-06 |
Recalls involving this device
No recalls on record reference this clearance.